Developing a biosimilar requires considerable investment and expertise. In order to maximize potential commercial return, biosimilar developers must adopt clear and effective strategies that leverage their internal capability and potentially capture the expertise of partners. Biosimilar developers need to assess the optimal strategies to implement early in product development to differentiate their biosimilar product from rival biosimilars and from the reference biologic. Companies that market reference brands are at risk of losing considerable revenue and need to adopt defensive strategies to limit or offset sales erosion. For both of these types of market players, determining the optimal strategy is challenging given the highly dynamic biosimilars environment and the need to factor in the impact of the evolving perceptions of key stakeholders such as physicians and payers.
Questions Answered in This Report:
- We have identified 178 partnerships that have been formed for the development of biosimilar biologics across various geographies, globally. What types of strategic partnerships have been forged for the development of biosimilars? What are the regions of relevance for biosimilar strategic alliances? Which biologic classes are the most common targets among biosimilar strategic partnerships? How are regional biosimilar developers establishing a regional and global footprint? Is the appetite for acquiring biosimilar developers increasing?
- We examine the optimal clinical trial strategies being pursued by biosimilar developers. How can Phase I trials which include both the U.S.- and EU-sourced reference product streamline later clinical development for a biosimilar intended for commercialization in these markets? What could be the impact of powering clinical trials to produce data where patients are switched between the reference brand and the biosimilar? How important are postapproval studies likely to be?
- Biosimilar manufacturers can consider robust marketing campaigns to promote biosimilar adoption. To what extent will marketing efforts of biosimilar manufacturers influence prescribing practices and inclusion on formularies? What types of biosimilar marketing exposure will be most influential in guiding physicians’ selection of one biosimilar over another?
- Multiple innovative branded biologic companies are at risk from significant biosimilar erosion across the seven major pharmaceutical markets. Which innovator companies stand to lose the greatest proportion of revenue as a result of biosimilar competition?
- Innovator biologics companies can utilize multiple defensive strategies to better compete with biosimilars. Strategies include adopting flexible pricing and novel value-add services, promotion of perception of greater reliability, and developing follow-on biobetters. To what extent will implementation of these strategies be successful in resisting erosion? To what extent are physicians and payers concerned about manufacturers guaranteeing a robust supply chain for biosimilars? How will counter-detailing strategies from branded biologic innovators influence physician prescribing preference?
Company strategies: Case studies describing biosimilar manufacturer’s strategies to promote biosimilar adoption and branded biologic innovator manufacturer’s strategies to limit or offset sales erosion biosimilar erosion.
Markets covered: Global assessment of strategic alliances for the development of biosimilars.
Primary research: Surveys with 548 specialist physicians across six different specialties in the United States and Europe. Surveys with an additional 61 U.S. managed care organization directors and 10 telephone interviews with key European payer advisors. Primary market research with key stakeholders to assess the following:
- Perceptions of biosimilar marketing campaigns.
- How postmarketing studies influence uptake of biosimilars.
- Extent to which counter-detailing influences stakeholder perceptions.
- Attitudes toward host-cell species for biosimilar development.
Biosimilar Strategic Alliances Deliverable: Assessment of 178 biosimilars-focused partnerships across nine drug classes and 22 molecules.